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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K254296

510(k) cleared

Ossiclear (Ossiclear System)

Sounduct · Jul 22, 2026 · K254296

FDA cleared the Ossiclear (Ossiclear System) from Sounduct on Jul 22, 2026 under K254296, a traditional 510(k). The device falls under product code LXB, Hearing Aid, Bone Conduction, regulated at 21 CFR 874.3302 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Dec 31, 2025. The decision came 203 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Sounduct in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254296?

K254296 is the FDA 510(k) for Ossiclear (Ossiclear System), submitted by Sounduct. FDA's decision date was Jul 22, 2026, under product code LXB (Hearing Aid, Bone Conduction).

Who makes the Ossiclear (Ossiclear System)?

Sounduct, based in Strasbourg, is the applicant of record for K254296.

How long did the K254296 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Jul 22, 2026, 203 days later.

← All decisions in July 2026